PainLIMITLESSNCT06621953
Is Low-load Resistance Training With Blood Flow Restriction More Effective Than Traditional Rehabilitation of Military Personnel With Lower Limb Injuries
A study testing BFR in people with Pain and Persistent Pain, run by Defence Medical Rehabilitation Centre, UK at 1 site in United Kingdom.
Trial summary
Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes. There are few exercise rehabilitation interventions able to relieve pain, thereby reducing the number of military personnel fit for operations. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain, Persistent Pain, Musculoskeletal Pain
- What is being tested?
- BFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Serving UK military personnel,
- Aged 18-55,
- Has unilateral lower limb injury whereby pain is the primary limiting factor hindering progression, as diagnosed by relevant consultant and team,
- Reduced occupational employability and function,
- Scheduled to attend DMRC Stanford Hall for 3 week residential rehabilitation course.
- MSK-Specific Exclusion Criteria
Show all 24Show fewer
- Any medical contraindication related to BFR*
- Non-musculoskeletal or serious pathological condition (i.e. Inflammatory arthropathy, infection or tumour)
- Spinal or referred pain from non-local pain source
- Any pre-diagnosed physical impairment or co-morbidities (including cardio-vascular disease) precluding the safe participation in the rehabilitation programme and/or assessment procedures
- Corticosteroid or analgesic injection intervention to the affected area within the previous 7 days
- Currently pregnant, or have not yet completed a return to work assessment following the birth of your child.
- Medical-Related Exclusion Criteria
- History of cardiovascular disease (hypertension, peripheral vascular disease, thrombosis/embolism, ischaemic heart disease, myocardial infarction),
- History of the following musculoskeletal disorders: rheumatoid arthritis, avascular necrosis or osteonecrosis, severe osteoarthritis
- History of the following neurological disorders: Alzheimer\'s disease, amyotrophic lateral sclerosis, peripheral neuropathy, Parkinson\'s disease, severe traumatic brain injury,
- Varicose veins in the lower limb,
- Acute viral or bacterial upper or lower respiratory infection at screening, Known or suspected lower limb chronic exertional compartment syndrome (CECS) (tourniquet raises intra-compartmental muscle pressure),
- Surgical insertion of metal components at the position of cuff inflation,
- History of any of the following conditions or disorders not previously listed:
- diabetes, active cancer,
- History of elevated risk of unexplained fainting or dizzy spells during physical activity and/or exercise that causes loss of balance,
- Increased risk of haemorrhagic stroke, exercise induced rhabdomyolysis,
- Currently pregnant.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Luke Hughes, PhD contact
United Kingdom1 site
Defence Medical Rehabilitation Centre, Stanford Hall
Loughborough, LE12 5QW
Peter Ladlow, PhD, +44 1509 251 500 ext. 3407, peter.ladlow100@mod.gov.uk
Luke Gray
About this study
Official title: The Effects of Different Blood Flow Restriction Training Methodologies During the Rehabilitation of Military Personnel With Lower Limb Musculoskeletal Injuries Primarily Limited by Pain: a 2 Part Randomised Controlled Trial (Phase Two)
Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes. There are few exercise rehabilitation interventions able to relieve pain, thereby reducing the number of military personnel fit for operations. Low load blood flow restriction (BFR) exercise has been shown to elicit an analgesic response and promote beneficial physiological changes in a variety of clinical populations.
This two phase study, aims to:
Read more
- Determine the most effective and feasible BFR resistance exercise protocol for reducing pain in UK military patients.
- Determine the efficacy of an optimal BFR exercise protocol for reducing pain and improving rehabilitation outcomes in UK military patients.
- Identify key physiological mechanisms underpinning any beneficial effect of BFR exercise on pain.
Consequently, results from this study will have direct clinical application and will aid best practice guidelines for the management of pain across Defence Rehabilitation by influencing the future rehabilitation paradigm. The investigators believe the results and impact will be far reaching, providing invaluable insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitaion, but also those working in civilian sector organisations and professional sport also.
- Conditions
- Pain, Persistent Pain, Musculoskeletal Pain
- Being tested
- BFR, control group
- Keywords
- blood flow restriction, pain, musculoskeletal
- Medical subject headings
- Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRDevice
Also called blood flow restriction training, occlusion training
The intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff is inflated to either 80% or 40% of limb occlusion pressure during lower limb strengthening exercises, as determined by Phase One (2318/MODREC/24a). These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum in Week 1, 25% in Week 2 and 30% in Week 3.
control groupOther
Standard residential rehabilitation consists of; (1) exercise-based therapy delivered in group settings and individually to address a variety of physical components relating to their pathology (e.g., balance and co-ordination, cardiovascular endurance, mobility and flexibility, motor control and dynamic stability, and muscular strength), (2) patient education sessions (e.g., activity modification, behavioural change, and focusing on pain management), and (3) one-on-one support sessions (e.g., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists).
| Study group | Role | What they receive |
|---|---|---|
| BFR | Experimental | The intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff will be inflated to either 40% or 80% of limb occlusion pressure during lower limb strengthening exercises, as determined by Phase One (2318/MODREC/24a). These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum. Receives: Device: BFR |
| Control | Active comparator | Standard residential rehabilitation consists of; (1) exercise-based therapy delivered in group settings and individually to address a variety of physical components relating to their pathology (e.g., balance and co-ordination, cardiovascular endurance, mobility and flexibility, motor control and dynamic stability, and muscular strength), (2) patient education sessions (e.g., activity modification, behavioural change, and focusing on pain management), and (3) one-on-one support sessions (e.g., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists). Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
The BPI is a patient administered, multi-dimensional, pain assessment tool commonly used within musculoskeletal clinical practice. Higher scores on the 9- item short form indicate greater interference with function, or greater pain intensity.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Secondary outcomes (29)
5-RM Testing
5-RM assessment on leg press and leg/knee extension machines (leg/knee extension pre-intervention only) to assess the participants strength, and inform % load for intervention period.
Testing procedure: 5-minute cycling warm up, followed by 10-rep exercise specific warm up, and then successive attempts at performing a 5RM on injured limb only. The authors acknowledge that due to the likely interference effect of a pain response, performing a \'maximum effort\' physical task in a lower limb injured cohort is unlikely to yield a true measure of MSK performance. It is more accurate to describe outcome scores as providing an \'indication\' of participant performance and progression. We will highlight this as a potential weakness in our study but feel this is a challenge in the measurement of muscle force / strength in all MSK injury research. All outcomes measured will be implemented and recorded based upon a best effort at the time of assessment.
Measured: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Numerical Pain Rating Scale
To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period. The Numerical Pain Rating Scale (NPRS) for injury-specific pain and localised muscle soreness will be collected pre-intervention, immediately post-intervention, and 1-hour post-intervention for each BFR-RT session.
Measured: T2, Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5, 6-10 and 11-15).
Sessional Rate of Perceived Exertion
To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period.
Sessional Rate of Perceived Exertion (scored 0-10; 0=no effort, 10=maximal effort) will be collected following each BFR-RT session.
Measured: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
Training Load
To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period.
To quantify training load, the following calculation will be conducted following each BFR-RT session; sets x reps x load (kg).
Specific Example:
BFR-RT Leg Press at 25kg
1 set x 30 reps + 3 sets x 15 reps = 75 reps 75 (reps) x 25 (kg) = 1875 (training load)
Measured: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
Copenhagen Hip and Groin Score
The Copenhagen Hip and Groin Score is a patient administered, multi dimensional, pain assessment tool commonly used to assess symptomatic and functional burden associated with hip and groin pathology. Scored from 0-100, lower scores on the HAGOS represent greater symptomatic and functional burden. The MCID per domain is 8, 8, 9, 10, 11, and 12 points for hip-related QOL, symptoms, pain, sport and recreation activities, ADL, and participation in physical activities, respectively.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Lower Extremity Function Scale
The LEFS is a patient-reported outcome measure that measures functional status in patients with lower limb musculoskeletal injury. Ability to perform 20 activities, ranging from walking to running on uneven ground, are self-reported from 0-4 with higher scores indicating better function.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Daily Morning Wellbeing
To assess the feasibility and tolerability of the BFR-RT interventions, a participant monitoring booklet will be used throughout the intervention period.
Daily morning wellbeing questions (fatigue, muscle soreness, sleep quality, stress levels and mood) will be asked each morning using a Likert scale (1-5), before the first BFR-RT session.
Measured: T2, Daily (before BFR session; days 1-5, 6-10 and 11-15).
Isometric Mid-Thigh Pull
The isometric mid-thigh pull is a test that can assess multiple derivatives of maximal lower-limb muscle strength including, peak force, rate of force development and limb asymmetry. The participant is asked to stand on force plates (set within a mid-thigh pull rig) and then pull on the mid-thigh bar at maximal force.
Measured: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Pressure Pain Threshold Testing
Pressure pain threshold assessment can help define regions of mechanical hypersensitivity, a common trait of central sensitisation. By utilising a digital pressure algometer (1cm^2 probe, Model FPX 50, Wagner Instruments, USA), the amount of pressure at which the sensation of pressure becomes unpleasant is deemed the PPT, with lower pressure values being indicative of central sensitisation.
Measured: T0, Pre-Admission (Day 0); T1, Course Admission (Day 1); T2, Daily (Day 1-5, Day 6-10, Day 11-15); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Foot and Ankle Disability Index
The Foot and Ankle Disability Index is a 26-item ankle and foot specific, patient- reported, questionnaire which considers ADLs, function, pain and sleep. Each item is scored from 0 (unable to do/unbearable pain) to 4 (no difficulty at all/no pain), with a total point value reaching a maximum of 104; however, the PROM is scored as a percentage and a lower percentage indicates greater levels of disability and/or pain. To date, no MCID has been reported for the Foot and Ankle Disability outcome measure.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score is a five domain, patient- administered questionnaire, used to monitor disease course and outcomes following knee injury/OA or surgery. The five domains, ADL, knee-related QOL, other symptoms, pain, and sport and recreation function, are scored on a 0- 100 scale, with a higher score indicating better function and less symptoms. The MCID for the Knee Injury and Osteoarthritis Outcome Score is 10-points for each domain.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Leeds Assessment of Neuropathic Symptoms and Signs
The Leeds Assessment of Neuropathic Symptoms and Signs is a self-reported questionnaire with a primary aim of distinguishing pain of a neuropathic origin, without the need for clinical assessment. The questionnaire consists of 7 questions, with a higher score suggesting the pain is predominantly of neuropathic origin. To date, no MCID has been reported for the Leeds Assessment of Neuropathic Symptoms and Signs.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Non-Arthritic Hips Score
The Non-Arthritic Hips Score is a 20-item, self-reported, questionnaire covering four domains (activities, function, pain and symptoms), in patients without arthritic pathology. The summative score for Non-Arthritic Hips Score is between 0-100, with 100 representing a perfectly functioning hip. The MCID for this outcome measure is 8-points.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Achilles
The Victorian Institute for Sport Assessment - Achilles is a patient-reported questionnaire designed to assess the severity of Achilles tendinopathy. With questions focused on the domains of function in ADLs, pain, and sporting activity, the questionnaire is scored out of 100 (100 = asymptomatic); however, a score less than 60 is often seen in Achilles tendinopathy populations. The MCID is set at 14-points for mid-portion Achilles tendinopathy, and 6.5 points for insertional tendinopathy.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Gluteal
The Victorian Institute for Sport Assessment - Glutealwas designed to evaluate the severity of disability in greater trochanteric pain syndrome populations. Formulated in the same manner as other Victorian Institute of Sport Assessment tendinopathy measures, the Victorian Institute for Sport Assessment - Gluteal is scored out of 100, with a greater score associated with greater function and less symptom impairment. There is currently no MCID reported within the literature for the Victorian Institute for Sport Assessment - Gluteal.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Hamstring
The Victorian Institute for Sport Assessment - Hamstring was designed in the style of previous Victorian Institute of Sport Assessment tendinopathy outcome measures, but specifically to evaluate the severity of symptoms, function and ability to play sports in those with proximal hamstring tendinopathy. Scored out of 100, with higher scores being associated with greater function and less symptomatic impairments. A 4-point reduction was reported in the literature as being the threshold required to detect for true change when the standard error of measurement is considered; however, an MDIC of 22-points has been reported.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Patella
The Victorian Institute for Sport Assessment - Patella is an 8 question, patient- reported measure developed specifically to subjectively assess the severity of symptoms, function and ability to play sports in those with patella tendinopathy .
Scored out of 100, a greater score is associated with greater function and less symptom impairment, with 0 being the theoretical minimum score. The MCID for the Victorian Institute for Sport Assessment - Patella is 13-points.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
McGill Pain Questionnaire - Short Form
The McGill Pain Questionnaire short form asks patients to rate 15 descriptors of affective and sensory feelings of pain (i.e., aching, sickening, throbbing) on a 1 (none) to 4 (severe) scale and completed a NPRS for average pain intensity. The affective and sensory section of the McGill Pain Questionnaire short form is graded from 15 to 45, with a higher score indicating a greater level of pain intensity and sensory variation; meanwhile, the NPRS of average pain is considered a separate entity. The MCID for this outcome measure is 5-points.
Measured: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Pain Catastrophizing Scale
The Pain Catastrophizing Scale is a 13-item instrument that assesses helplessness, magnification and rumination to encompass the catastrophizing of musculoskeletal persistent pain. With each item scored 0 (not at all) to 4 (all the time), a higher score indicates greater catastrophizing of pain. A MCID of 8- and 11-points for no/low catastrophizers and catastrophizers (total score = \>30 points), respectively, has been reported within the literature.
Measured: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia is a 17-item questionnaire used to evaluate kinesiophobia in people with persistent musculoskeletal pain, by assessing activity avoidance (i.e., reflects beliefs of an activity that may result in an increase of pain, or cause injury) and somatic focus (i.e., reflects beliefs and underlying of serious conditions). With each item scored 1 (strongly disagree) to 4 (strongly agree), a higher score denotes greater levels of fear of movement and/or re-injury. The MCID for Tampa Scale of Kinesiophobia is a 4-point reduction.
Measured: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Fatigue Assessment Scale
The Fatigue Assessment Scale is a 10-question, self-reported questionnaire that covers mental and physical fatigue. The cumulative score for the Fatigue Assessment Scale ranges from 10 to 50, with each question is scored from 1 (never) to 5 (always), with two requiring reverse scoring. A higher score indicates greater levels of fatigue, with scores \>22 representing fatigue levels are greater than "healthy" or "normal" levels. The MCID for the Fatigue Assessment Scale is 4-points.
Measured: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Temporal Summation
Temporal summation is form of quantitative sensory testing that utilised mechanical pressure to gain insight to which pain mechanisms are involved for an individual patient. Temporal summation assessment resembles the "wind-up" effect, or second pain stimulus, often seen in persistent pain populations. To assess temporal summation, at a pre-determined location closest to the individuals injured site, ten consecutive ramping pulses building to the mean pressure of the respective PPT score will be applied over 5s with a 1s hold, before immediate release, with 1s rest interval before the next pulse. At the peak of each pulse, the participant will be asked to rate their pain on the NPRS scale. The first NPRS value will act as an anchor/baseline. Each NPRS will be normalised via subtraction of the initial NPRS value. To reflect changes in temporal summation across the series, the NPRS epochs (mean NPRS rating of peaks; I 2-4, II 5-7, and III 8-10) will be calculated for analysis.
Measured: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Beta Endorphin
Beta-endorphin is a neuropeptide produced in the central nervous system and pituitary gland in response to pain or exercise will be collected via venepuncture or cannulation to assess the acute response of BFR-RT on hypoalgesia.
Measured: T0, Pre-Admission (Day 0); T2, Daily (Day 2, 7 and 11 pre-, post- and 1-hour post-intervention, Day 3, 8, and 12 pre-intervention); T3, Start and End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Interluekin-6
Inflammatory cytokine, interleukin-6, is thought to be a driver for the development of pathological pain and has been shown to have elevated levels in persistent pain populations. This will be collected via venepuncture or cannulation to assess the response of BFR-RT on systemic inflammatory markers.
Measured: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Tumour Necrosis Factor Alpha
Inflammatory cytokine, tumour necrosis factor alpha, is thought to be a driver for the development of pathological pain and has been shown to have elevated levels in persistent pain populations. This will be collected via venepuncture or cannulation to assess the response of BFR-RT on systemic inflammatory markers.
Measured: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Medication Record Sheet
The medication record sheet is utilised to show what current medications each participant is using for their pathology. The drug name, drug purpose, dose size and frequency is noted. This outcome measure is taken at baseline only (T0).
Measured: T0, Pre-Admission (Day 0).
Demographics Questionnaire
Personal and demographic characteristics including age, body height, body mass, body mass index, duration of symptoms, previous injuries, previous treatment, military occupation, duration of military service, smoking and drinking habits. This outcome measure is taken at baseline only (T0).
Measured: T0, Pre-Admission (Day 0).
Health Anxiety Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-reported measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. This outcome measure is taken at baseline only (T0).
Measured: T0, Pre-Admission (Day 0).
Musculoskeletal Health Questionnaire
The MSK-HQ is a self-reported questionnaire that allows people with musculoskeletal conditions to report their symptoms and quality of life in a standardised way. This outcome measure is taken at baseline only (T0).
Measured: T0, Pre-Admission (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Jun 2025 (estimated)
- Primary completion29 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The overall study is a two phase RCT. Phase one will investigate two different BFR-RT protocols (high- vs low-pressure) for 1-week (7x BFR-RT sessions in 5 days). Phase two will take the BFR-RT protocol that elicited the greatest improvement in symptoms (high- or low-pressure) and compare that to conventional UK Defence Rehabilitation practices over a 3 week period (21x BFR-RT sessions over 15 days). Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defence Medical Rehabilitation Centre, UK
- Sponsor type
- Other government
- Collaborators
- Northumbria University
- Responsible party
- Principal investigator, Peter Ladlow, Defence Medical Rehabilitation Centre, UK
- Investigators
- Peter Ladlow, PhD, Principal investigator, Defence Medical Rehabilitation Centre, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621953
- Sponsor's protocol ID
- 2318/MODREC/24b
- Acronym
- LIMITLESS
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, grouped data (i.e., data that cannot individually identify participants) may be shared to other research groups for the advancement of research and clinical practices, by the chief investigator.
Publications
Gray L, Coppack RJ, Barker-Davies R, Cassidy RP, Bennett AN, Caplan N, Atkinson G, Bradshaw L, Chauhan J, Lunt KM, Hughes L, Ladlow P. Efficacy and acceptability of different blood flow restriction training interventions during the rehabilitation of military personnel with lower limb musculoskeletal injuries: protocol for a two-phase randomised controlled trial. BMJ Open. 2025 May 26;15(5):e096643. doi: 10.1136/bmjopen-2024-096643.
PubMed 40425246
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Blood Flow Restriction Training Methodologies During the Rehabilitation of Military Personnel With Lower Limb Musculoskeletal Injuries Primarily Limited by Pain: a 2 Part Randomised Controlled Trial (Phase Two)
- ClinicalTrials.gov ID
- NCT06621953
- Acronym / sponsor ID
- LIMITLESS / 2318/MODREC/24b
- Conditions
- Pain, Persistent Pain, Musculoskeletal Pain
- Keywords
- blood flow restriction, pain, musculoskeletal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Defence Medical Rehabilitation Centre, UKOther government
- Collaborators
- Northumbria University
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes. There are few exercise rehabilitation interventions able to relieve pain, thereby reducing the number of military personnel fit for operations. Low load blood flow restriction (BFR) exercise has been shown to elicit an analgesic response and promote beneficial physiological changes in a variety of clinical populations.
This two phase study, aims to:
- Determine the most effective and feasible BFR resistance exercise protocol for reducing pain in UK military patients.
- Determine the efficacy of an optimal BFR exercise protocol for reducing pain and improving rehabilitation outcomes in UK military patients.
- Identify key physiological mechanisms underpinning any beneficial effect of BFR exercise on pain.
Consequently, results from this study will have direct clinical application and will aid best practice guidelines for the management of pain across Defence Rehabilitation by influencing the future rehabilitation paradigm. The investigators believe the results and impact will be far reaching, providing invaluable insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitaion, but also those working in civilian sector organisations and professional sport also.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The overall study is a two phase RCT. Phase one will investigate two different BFR-RT protocols (high- vs low-pressure) for 1-week (7x BFR-RT sessions in 5 days). Phase two will take the BFR-RT protocol that elicited the greatest improvement in symptoms (high- or low-pressure) and compare that to conventional UK Defence Rehabilitation practices over a 3 week period (21x BFR-RT sessions over 15 days). Due to the nature of the intervention, it is not possible to blind participants or outcome assessors to the treatment allocation. There is also no effective sham condition available. This is a common limitation within all blood flow restriction training research.
| Arm | Type | Receives |
|---|---|---|
| BFR | Experimental | Device: BFRThe intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff will be inflated to either 40% or 80% of limb occlusion pressure during lower limb strengthening exercises, as determined by Phase One (2318/MODREC/24a). These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum. |
| Control | Active comparator | Other: control groupStandard residential rehabilitation consists of; (1) exercise-based therapy delivered in group settings and individually to address a variety of physical components relating to their pathology (e.g., balance and co-ordination, cardiovascular endurance, mobility and flexibility, motor control and dynamic stability, and muscular strength), (2) patient education sessions (e.g., activity modification, behavioural change, and focusing on pain management), and (3) one-on-one support sessions (e.g., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Serving UK military personnel,
- Aged 18-55,
- Has unilateral lower limb injury whereby pain is the primary limiting factor hindering progression, as diagnosed by relevant consultant and team,
- Reduced occupational employability and function,
- Scheduled to attend DMRC Stanford Hall for 3 week residential rehabilitation course.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFRAlso: blood flow restriction training, occlusion trainingThe intervention involves placing a pneumatic tourniquet system over the proximal thigh. The cuff is inflated to either 80% or 40% of limb occlusion pressure during lower limb strengthening exercises, as determined by Phase One (2318/MODREC/24a). These exercises include leg press and knee extensor exercises. Four sets (30,15,15,15 repetitions) performed at 20% of one repetition maximum in Week 1, 25% in Week 2 and 30% in Week 3. | Device | BFR |
| control groupStandard residential rehabilitation consists of; (1) exercise-based therapy delivered in group settings and individually to address a variety of physical components relating to their pathology (e.g., balance and co-ordination, cardiovascular endurance, mobility and flexibility, motor control and dynamic stability, and muscular strength), (2) patient education sessions (e.g., activity modification, behavioural change, and focusing on pain management), and (3) one-on-one support sessions (e.g., dietetics, occupational therapy, physiotherapy, podiatry, prosthesis/orthosis specialists, social workers, and speech and language therapists). | Other | Control |
Primary outcome
Brief Pain Inventory
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
The BPI is a patient administered, multi-dimensional, pain assessment tool commonly used within musculoskeletal clinical practice. Higher scores on the 9- item short form indicate greater interference with function, or greater pain intensity.
29 secondary outcomes
5-RM Testing
Time frame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Numerical Pain Rating Scale
Time frame: T2, Daily (before, immediately-post, and 1 hour-post each BFR session; days 1-5, 6-10 and 11-15).
Sessional Rate of Perceived Exertion
Time frame: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
Training Load
Time frame: T2, Daily (immediately post-intervention; day 1-5, 6-10 and 11-15).
Copenhagen Hip and Groin Score
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Lower Extremity Function Scale
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Daily Morning Wellbeing
Time frame: T2, Daily (before BFR session; days 1-5, 6-10 and 11-15).
Isometric Mid-Thigh Pull
Time frame: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Pressure Pain Threshold Testing
Time frame: T0, Pre-Admission (Day 0); T1, Course Admission (Day 1); T2, Daily (Day 1-5, Day 6-10, Day 11-15); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Foot and Ankle Disability Index
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Knee Injury and Osteoarthritis Outcome Score
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Leeds Assessment of Neuropathic Symptoms and Signs
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Non-Arthritic Hips Score
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Achilles
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Gluteal
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Hamstring
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Victorian Institute for Sport Assessment - Patella
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
McGill Pain Questionnaire - Short Form
Time frame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Pain Catastrophizing Scale
Time frame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Tampa Scale of Kinesiophobia
Time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Fatigue Assessment Scale
Time frame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Temporal Summation
Time frame: T0, Pre-Admission (Day 0); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Beta Endorphin
Time frame: T0, Pre-Admission (Day 0); T2, Daily (Day 2, 7 and 11 pre-, post- and 1-hour post-intervention, Day 3, 8, and 12 pre-intervention); T3, Start and End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Interluekin-6
Time frame: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Tumour Necrosis Factor Alpha
Time frame: T0, Pre-Admission (Day 0); T3, Start and End of Residential Rehabilitation Week (Day 5, 6, 10 and 11); T4, Post-Intervention/Pre-Course Discharge (Day 15)
Medication Record Sheet
Time frame: T0, Pre-Admission (Day 0).
Demographics Questionnaire
Time frame: T0, Pre-Admission (Day 0).
Health Anxiety Depression Scale
Time frame: T0, Pre-Admission (Day 0).
Musculoskeletal Health Questionnaire
Time frame: T0, Pre-Admission (Day 0).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 40425246Gray L, Coppack RJ, Barker-Davies R, Cassidy RP, Bennett AN, Caplan N, Atkinson G, Bradshaw L, Chauhan J, Lunt KM, Hughes L, Ladlow P. Efficacy and acceptability of different blood flow restriction training interventions during the rehabilitation of military personnel with lower limb musculoskeletal injuries: protocol for a two-phase randomised controlled trial. BMJ Open. 2025 May 26;15(5):e096643. doi: 10.1136/bmjopen-2024-096643.
- Individual participant dataSharing planned: Yes. Upon reasonable request, grouped data (i.e., data that cannot individually identify participants) may be shared to other research groups for the advancement of research and clinical practices, by the chief investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Hughes, PhD contact
Peter Ladlow, PhD principal investigator
Defence Medical Rehabilitation Centre, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR in people with Pain and Persistent Pain, run by Defence Medical Rehabilitation Centre, UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Ladlow, PhD (+44 1509 251 500 ext. 3407, peter.ladlow100@mod.gov.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: T0, Pre-Admission (Day 0); T3, End of Residential Rehabilitation Week (Day 5 and 10); T4, Post-Intervention/Pre-Course Discharge (Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.